BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAGLENE GUIDE PIN DIA 2.5MM

    MDR report key: 9882566 · Received March 26, 2020

    Report

    Report Number
    1818910-2020-09283
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 10, 2020
    Report Date
    March 10, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    UDI-DI
    10603295116455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: ADDED: DEVICE IDENTIFICATION (LOT #), CONCOMITANT MEDICAL PRODUCTS, INITIAL REPORTER NAME AND ADDRESS, DEVICE MANUFACTURE DATE AND EVALUATION CODES. CORRECTED: DEVICE EVALUATED BY MFR. PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE PROLONGED SURGERY AND INSUFFICIENT INFORMATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : FOLLOWING REVIEW OF THE INFORMATION RECEIVED, IT WAS CONCLUDED THAT IT WAS UNLIKELY THAT A POTENTIAL PRODUCT ISSUE WAS PRESENT. THE COMPLAINT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE REVIEWED AND FURTHER INVESTIGATION COMPLETED AS REQUIRED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DELTA XTEND SURGERY - WANTED TO PLACE THE METAGLENE POSITIONING PLATE 2307-87-003 AND DRILL THE 2307-87-004 METAGLENE CENTRAL GUIDE PIN Ø 2.5 MM BY INSERTING IT THROUGH THE WHOLE OF THE PLATE. BUT THE PIN DIDN'T FIT THROUGH THE WHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345618 METAGLENE GUIDE PIN DIA 2.5MM EXTREMITY INSTRUMENTS : PIN GUIDES LXH DEPUY FRANCE SAS - 3003895575 2307-87-004 5356507 10603295116455

    Patients

    Seq Age Sex Outcome Treatment
    1